Calcium Dobesilate for Chronic Venous Wounds

February 16, 2011 updated by: Fundacion Iberoamericana Itaca

Randomized, Double-blind Multicenter Clinical Trial Comparing the Efficacy of Calcium Dobesilate With Placebo in the Treatment of Ulcer Secondaries to Chronic Venous Disease

The objective of the study is to assess the efficacy of calcium dobesilate for treating chronic venous wounds.

The hypothesis is that venous ulcers treated with standards measures (compressive measures) and calcium dobesilate will heal-up better than venous ulcers treated with standards measures (compressive measures) and placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Hospital General de Albacete
      • Barcelona, Spain, 08025
        • CAP Joanic
      • Barcelona, Spain
        • Hospital Platon
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Leon, Spain, 24071
        • Hospital de Leon
      • Logroño, Spain, 26006
        • Hospital San Pedro de Logroño
      • Madrid, Spain, 28005
        • Hospital La Princesa
      • Madrid, Spain, 28905
        • Hospital Clinico Universitario San Carlos
      • Mallorca, Spain, 07014
        • Complejo Hospitalario de Son Dureta
      • Valladolid, Spain, 47005
        • Hospital Clinico Universitario de Valladolid
    • Asturias
      • Gijon, Asturias, Spain, 33394
        • Hospital de Cabueñes
      • Oviedo, Asturias, Spain, 33006
        • Hospital Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Tries i Pujol
      • Calella, Barcelona, Spain, 08370
        • Hospital Sant Jaume de Calella
      • Castelldefels, Barcelona, Spain, 08660
        • Cap El Castell
      • Granollers, Barcelona, Spain, 08402
        • Hospital General de Granollers
      • Mataró, Barcelona, Spain, 08304
        • Consorci Hospitalari de Mataró
      • Pineda de Mar, Barcelona, Spain, 08397
        • CAP Pineda de Mar
      • Sabadell, Barcelona, Spain, 08208
        • Corpotació Sanitària Parc Taulí
      • Sitges, Barcelona, Spain, 08870
        • CAP Sitges
      • Vic, Barcelona, Spain, 08500
        • CAP El Remei
      • Vic, Barcelona, Spain, 08500
        • Hospital de Vic
      • Vilassar de Mar, Barcelona, Spain, 08340
        • CAP Doctor Guillermo Masriera i Guardiola
    • Cataluña
      • Barcelona, Cataluña, Spain, 08015
        • CAP les Corts
      • Barcelona, Cataluña, Spain, 08025
        • CAP Gaudí
      • Barcelona, Cataluña, Spain, 08025
        • CAP Sagrada Familia
      • Barcelona, Cataluña, Spain, 08025
        • CAP Vila de Gracia
      • Barcelona, Cataluña, Spain, 08025
        • EAP Sardenya
      • Barcelona, Cataluña, Spain, 08025
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Cataluña, Spain, 08025
        • Hospital Dos de Maig
      • Barcelona, Cataluña, Spain, 08027
        • CAP la Sagrera
      • Barcelona, Cataluña, Spain, 08036
        • CAPSE
      • Barcelona, Cataluña, Spain, 08041
        • ABS Encants
      • Barcelona, Cataluña, Spain, 902011040
        • ABS Lesseps
      • Barcelona, Cataluña, Spain, 902011040
        • CAP la Salut
      • Barcelona, Cataluña, Spain
        • CAP Barceloneta
      • Barcelona, Cataluña, Spain
        • CAP Vila Olimpica
    • Girona
      • Peralada, Girona, Spain, 17491
        • CAP Albera Salut
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Fundacion Hospital de Alcorcon
      • Getafe, Madrid, Spain, 28905
        • Hospital de Getafe
    • Tarragona
      • Reus, Tarragona, Spain, 43201
        • Hospital Sant Joan de Reus
      • Vilarrodona, Tarragona, Spain, 43814
        • CAP Vila-Rodona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with venous ulcer (CEAP 6) that affect epidermis, dermis and/or subcutaneous tissue, with and area superior to 3 cm2
  • Ankle-arm index 0.9 or superior
  • Written informed consent of the patients

Exclusion Criteria:

  • Patients with venous ulcer (CEAP 6) that affect bone or with and area inferior to 3 cm2
  • Ankle-arm index inferior to 0.9
  • No written informed consent of the patients
  • Diabetes mellitus I y II
  • Patients with renal failure and dialysis
  • Vascular surgery needed
  • Impossibility to use compressive measures on the leg
  • Use of topic antibiotics, silver dressing, growth factors, plasma-rich in platelets, skin graft, pentoxifylline, ultrasounds, laser, hyperbaric oxygen, electric stimulation o vacuum.
  • Pregnancy
  • Breast feeding
  • No anticonceptives measures
  • Allergy or intolerance to phebotonics
  • Background of neutropenia or leucopenia
  • Basal leucocytes < 3.500/ml

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Calcium Dobesilate
Drug: Calcium Dobesilate
500 mg/ three times/day for 6 months (capsules)
Other Names:
  • Doxium
Placebo Comparator: Placebo
The placebo is a capsule with the same presence of experimental drug.
Drug: Calcium Dobesilate
500 mg/ three times/day for 6 months (capsules)
Other Names:
  • Doxium

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Healed venous ulcers
Time Frame: at 6 months of treatment
at 6 months of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of re-epithelization area (cm2)
Time Frame: at 6 month of treatment
at 6 month of treatment
Length of time to heal ulcers
Time Frame: during all the period of the study (12 months)
during all the period of the study (12 months)
Ulcer recurrence
Time Frame: at 12 month
at 12 month
Ulcer pain
Time Frame: at 6 and 12 months
at 6 and 12 months
Safety
Time Frame: during the study (12 months)
during the study (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion Iberoamericana Itaca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Laboratorios del Dr. Esteve, S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Moreno Carriles, Rosa Mª, Hospital La Princesa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007-002858-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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